An interventional study of Physical Exercise and Stress management training A in Compulsive Behavior, sponsored by Monash University. Completed at 1 site in Australia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Monash University · Not applicable, Interventional, and Treatment
Following the realisation that many aspects of the way we live our life, such as our diet, activity levels, and amount of screen time, can have a potent impact on mental health and brain functioning 'lifestyle' based interventions have become topical in medical research. In particular, much scientific attention has been devoted to the impact of physical exercise and various stress reduction techniques on mood disorders. We aim to extend this work and investigate their impact on compulsivity.
We will do this by conducting a pilot proof-of-principal intervention study. The study will compare the impact of eight-weeks of:
The participant cohort will be adults who endorse mild-moderate behavioural compulsivity on one of the following domains:
This study is investigating the impact of regular physical exercise and stress management activities on mental health and brain function. It is specifically focusing on how engaging in these activities might impact activity in brain circuits associated with compulsivity, and help to reduce compulsive patterns of behaviour.
A compulsive behaviour is something that we do regularly, feel pressured to do, and have difficulty stopping even though it is not benefiting us. Having compulsive patterns of behaviour is very common. It's been estimated that as many as 80% of the general population experience compulsivity at some point in their lives. That's most of us! Compulsive behaviours range in severity from mild to entrenched, and can take many forms. For example, gambling too often or washing ones hands excessively. For some people what starts out as a mild pattern of behaviour, such as a glass of wine every night after a stressful day, can develop into a problem, like alcohol dependence. As so many people experience mild to moderate compulsivity it would be helpful to have accessible evidence-based strategies that reduce compulsive tendencies.
One promising candidate is physical exercise. In addition to the well-known physical health benefits, regular exercise also has a potent positive effect on brain health and mental well being. Other candidates are specific stress management activities. Certain stress management techniques, such as brain training, meditation, psycho-education, music therapy, yoga, and guided relaxation, can promote optimal mental health, improve cognitive functioning and help keep the body's physiological arousal systems within a healthy range. Some stress management activities may also help to reduce compulsive behavioural patterns. Importantly, as physical exercise increases neuroplasticity (i.e. malleability of the brain), engaging in regular exercise may enhance the effectiveness of concurrent stress management activities.
This research study is investigating the impact of eight-weeks of regular physical exercise paired with two different stress management activities on brain health, mental health, and compulsivity. Both of these activities have previously been shown to reduce stress and improve mental health, we are investigating whether one is more effective than the other.
As regular exercise and stress management training are time consuming, taking part in the study will reduce the opportunity to engage in compulsive behaviours. As such, our primary focus for the study will not be a reduction in the time spent engaging in compulsive behaviour. Instead, we will focus on whether the interventions modulate aspects of brain function associated with compulsivity (e.g. hippocampal integrity, functional brain activity during reward processing), aspects of cognition associated with compulsivity (e.g. affective processing bias and decision making), indices of the bodies stress system (e.g. cortisol awakening response), and aspects of mental health and quality of life that can be compromised in sub-clinical compulsive populations (e.g. experiential avoidance, general well being, symptoms of anxiety and depression).
30 studies on the registry are indexed under Compulsive Behavior; 6 are open to participants now.
This study's enrollment of 69 is above the median of 50 across 27 interventional studies indexed under Compulsive Behavior.
Browse Compulsive Behavior studies →Monash University is the lead sponsor of 83 studies on the registry; 22 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eight week program of concurrent exercise and stress management training.
Behavioral: Physical Exercise · Behavioral: Stress management training A
Eight week program of concurrent exercise and stress management training.
Behavioral: Physical Exercise · Behavioral: Stress management training B
Eight weeks period with no alteration of usual lifestyle. Participants randomized to this arm are eligible for re-randomisation to one of the active conditions at the conclusion of week eight.
Physical exercise: Amount of time exercising gradually titrated from 90-minutes in week one to 180-minutes in week eight. Intensity titrated concurrently from 40 - 60% VO2 max in week one to 40 - 90% VO2 max in week eight. Eight week gym membership provided to all participants to facilitate engagement in exercise.
Stress management training A: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.
Stress management training B: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.
Change in hippocampal integrity
Composite score of hippocampal health indices, including volume (structural MRI) and neuronal NAA levels (MRS).
Time frame: Baseline (0 months), post (2 months)
Change in functional activation during reward processing
fMRI Monetary Incentive Delay Task
Time frame: Baseline (0 months), post (2 months)
Change in cortisol awakening reponse
Salivary cortisol
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in affective processing bias
BeanFest
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in risky decision making
Balloon Analogue Risk Task
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in behavioral compulsivity
Transdiagnositc YBOCS
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in psychosocial well being
Battery of self-report mental health and well being questionnaires assessing: symptoms of depression and anxiety, experiential avoidance, tolerance of uncertainly, impulsivity, obsession beliefs, well being, self efficacy, quality of life, and quality of inter-personal support.
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Change in physical fitness
VO2 max
Time frame: Baseline (0 months), post (2 months), follow up (three months)
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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